Literature Review

BioReg Services specializes in systematic literature searches and reviews in compliance with the MDR Regulation (EU) 2017/745 and MEDDEV 2.7/1 rev.4 (2016) guidance. Our team can design a comprehensive literature search protocol with complete documentation of the literature screening and data extraction process. We can obtain clinical evidence for the literature review for your new medical device or update the literature review of a CE-marked or legacy device to create an MDR compliant document.

See our 3-part series blog about the Medical Device Literature Review Part 1, Part 2 and Part 3.

 

Important Links

MEDDEV 2.7/1 rev.4 (2016) CLINICAL EVALUATION

 

 

CONTACT US

In order to inquire about our services or ask for immediate regulatory advice for your product, contact us.

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